Method and apparatus for hemodialysis

ABSTRACT

A chamber for receiving an artificial kidney dialysis coil, employing the coil for hemodialysis of a patient and storing the coil under sterilization conditions between uses. The chamber is employed in a method of hemodialysis permitting of repeated use of the same coil.

United States 1e 11 1 Snyder June 11, 1974 [54] g ggfggi fig g FOR OTHERPUBLICATlONS Pollard et 111., A Technique for Storage and Multiple 1Inventofl Donald y v 140 Hewett Nick Re-Use of the Kiil Dialyzer andBlood Tubing,

Hewlett Neck Transactions of the American Society of Artificial In- [22]Filed; June 1971 ternal Organs, Vol. XIII, 1967, copy in Op. 176. pages24-28 relied on. 211 Appl. No.: 151,324

Primary Examiner-Frank A. Spear, Jr. [52] US. Cl 210/94, 210/321,210/494 n y. Ag n r FirmLeonard H. King [51] llnt. Cl BOld 31/00 7 [58]Field of Search 210/321, 494, 500. 22, [57] ABSTRACT 210/94 A chamberfor receiving an artificial kidney dialysis coil, employing the coil forhemodialysis of a patient [56'] References cum and storing the coilunder Sterilization conditions be- UNITED STATES PATENTS tween uses. Thechamber is employed in a method of 3,140,256 7/1964 Martin et al.210/500 X hemodialysis permitting of repeated use of the same 3,357,56512/1967 Burger 1 1 210/494 X coil 1 I 3.508662 4/1970 Miller.... 210/494X 3.712.475 1/1973 Martinez 210/494 x 7C1am1s, 5 Drawing Figures 5? 62627 50 I; 4 63 1 1 1 V 1 l I I 1 ,4 W I I I I 1 ii i i I! I I l 5 l h- 4l 1 l i 1 L2 ll 1 PATENTEDJHN 1 mm 11815743 saw ear 2 INVENTOR. DON/4 LD SYNDE'R A T TORNE Y METHOD AND APPARATUS FOR MODIALYSIS BACKGROUND OFTHE INVENTION This invention relates to hemodialysis devices. Manypatients suffering from chronic renal insufficiency are required toemploy chronic hemodialysis to survive. It is reported that from sevento nine thousand persons lose their lives annually because of theunavailability of funds to cover the initial cost of the equipment andhigh cost of operating the equipment.

The present invention is directed to a method of substantially reducingthe daily operating cost of hemodialysis machines. A typical patientwill require six hours of hemodialysis three days per week and the needfor a disposable coil kidney costing presently about $18.00 per unit.Some patients take a daily treatment. Thus, the cost of disposable coilsranges from about $54.00 to $120.00 a week. On the other hand, thepresent invention extends the life of a single disposable unit to atleast six uses. Accordingly, operating cost of the equipment is greatlyreduced.

In simple terms, the coil kidney consists of two parallel cellulosemembrane tubes or synthetic diffusive membrane tubes enveloped incoarse, porous, open mesh supporting screens. These tubes, and theirscreens, are coiled about a central core, to form a compact yet highlyefficient cylindrical shape. In operation, blood flows through themembrane tubing while the dialyzing fluid flows freely about the outsideof the tubing. The apparatus of this invention is compatible withpresent day dialysis machines and the mode of operation for ordinarydialysis is the same as the present day devices. Therefore, it does notrequire any modification of equipment.

There are advantages in reusing the coil six times in that the rupturerate of coils is significantly lower than that of new coils. New coilshave a failure rate of approximately one of six. On the other hand, onlyone rupture of a previously used coil occurred in reuse of sixty-sixcoils. This corresponds to about one failure per four hundred dialysistreatments. The reasons for this improvement are:

l. Defective coils have been eliminated from the program.

2. The coils have been subjected to a toughening teatment.

The advantages go beyond mere cost of coils for when a coil ruptures thepatient faces shock and loss of blood. Since dialysis subjects aregenerally anemic, a blood transfusion is usually required.

BRIEF SUMMARY OF THE INVENTION A special chamber is provided for use inconjunction with a standard hemodialysis machine, such as that suppliedby Travenol Laboratories, lnc., Morton Grove, Illinois. The chamberaccepts the standard dialysis membrane element and permits operating thehemodialysis machine in its conventional manner. Following a completionof the prior art hemodialysis cycle, the coil is normally discarded.Instead, in this case, the coil is flushed free of blood and thenimmersed in a sterilizing solution contained within the chamber. Covermeans are provided for sealing the chamber during the storage cycle.

Accordingly, it is an object of this invention to provide an improvedmethod of hemodialysis.

It is a particular object of this invention to provide a method forreusing artificial kidney coils.

It is a further object of this invention to provide a method forstrengthening artificial kidney coils.

A still different object of this invention is to provide an improvedapparatus for hemodialysis.

A further object of this invention is to provide a chamber for anartificial kidney coil which is suitable for use in dialysis and forstorage of the artifical kidney coil.

These and other objects, features and advantages of the invention will,in part, be pointed out with particularity and will, in part, becomeobvious from the following more detailed description of the inventiontaken in conjunction with the accompanying drawing which forms anintegral part thereof.

FIG. 1 is a schematic diagram of a prior art hemodialysis apparatus;

FIG. 2 is a sectional view in elevation of a chamber containing a kidneycoil, the chamber being arranged for dialysis;

FIG. 3 is a sectional view in elevation of the chamber of FIG. 2arranged for a storage mode;

FIG. 4 is a partial section taken along line 4-4 of FIG. 3; and

FIG. 5 is a plan view taken along line 5-5 of FIG. 4.

DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 shows schematically atypical hemodialysis apparatus. For purpose of simplicity, variousreagent injecting devices and other apparatus not essential for theexplanation of the present invention have been omitted. The apparatusincludes a kidney tank coil holder 10 which receives a Kolff dialysismembrane element 12 generally referred to as a kidney coil. The coil issurrounded by an inflatable cuff 14. This cuff seals off the kidney coilfrom the wall of the tank, thereby causing dialysis fluid pumped fromstorage tank 16 by pump 18 into the kidney tank coil through thesupporting mesh 20 where it washes the walls of membranes 22 (FIG. 2).An inlet tube is connected to the patients arterial system and suppliesblood by means of blood pump P to coil inflow tubes 34. It isconventional to use a pair of parallel membrane tubes in the kidney coilapparatus. The outflow from the kidney coil passes through tubes througha bubble trap chamber T and to tube 38 which is connected to thepatients venous system. .At the present time all devices on the outletside of coupling members 40 are disposed of after one use. On the otherhand, the inlet tube 30, resterilized as explained hereinafter, may bereused three times in conjunction with this invention. Using theapparatus and procedure described hereinafter the kidney coil may bereused approximately six times. As liquid is pumped from the storagetank into the kidney tank coil holder, the overflow or waste liquid isrun out to a disposal drain (not shown).

Referring now to FIG. 2, there is shown a chamber of this invention.This chamber is preferably made of a transparent material which can besterilized, such as glass or suitable plastics, such aspolymethylmethacryate. This chamber is comprised of a tubular shellmember 40 having affixed thereto a base portion 42. Extending from baseportion 42 there is a tubular member 44 adapted to be coupled to theconduit leading to the pump and sealed thereto by means of teflon cuff45. Openings 43 admit fluid to the interior of the tubular member 44.The size of openings 43 should be at least equal to the cross-sectionalarea of the tube member 44.

Lever 50 pivots on pivot shaft 51 raising hollow shaft 52 to lift valve53 and O ring 54 away from seat 55. In this condition dialysis fluidfrom pump 18 is permitted to flow into the chamber. Lever arm 50 iscoupled by means of linkage 58 to actuating knob 59. Linkage 58 includesmembers 61, 61 joined by a tension spring 61. The knob is provided witha shaft which may be positioned in detent slot 60 as shown in FIG. 4, tomaintain a cover member 62 in an open position. Pressure of the dialysisfluid lifts the coil 12 against stop 27. In this condition the patientis subjected to the dialysis treatment.

Preparation for Storage Upon completion of the hemodialysis procedurethe blood in the coil is discharged to the patient by pumping normalsaline through the line. Thereafter the patient is disconnected from thevenous line and pumping continued until air has completely evacuated thesaline from the coil. The coil is then disconnected from the venousline. The two coupling fittings 40 at the end of the coil line are thenplaced in the bottom of the central core of the coil. The pneumatic cuffsurrounding the coil is deflated and the end 17 of the pneumatic cuffline 19 is placed on the surface of the kidney coil. The bifurcatedarterial lines 30, 30' are then disconnected from the coil line 34 atconnectors 33 and are connected to opposite ends of the fittings 50, 51which extend through the cover 62 of the chamber. The bottom valve 53 isthen closed against ring seal 54. The cover 62 is closed against 0 ring62 and clamped by means of clamp members 63 which seat in grooves 65(FIG.

The coil is now filled with sterilizing solution. The patients end ofthe arterial line A is connected to a one liter container of sterilizingsolution and approximately a liter of sterilizing solution is pumpedinto the coil and overflows into the chamber. The sterilizing solutionis allowed to rise several inches into the intravenous tubing connectedto the T-tube 39 of the arterial line A. Below the upper level of thesterilizing solution the intravenous tubing is closed by clamp 31 andcut at point C.

When only a few ccs remain within the one liter container pumping isstopped and the arterial line A disconnected from the one litercontainer.

The patients end of the arterial line A is connected to the top offitting 52. The other end of fitting 52 is exposed to the inside of thechamber. In order to connect the male fittings at the three ends of thearterial line to the simple tubular stainless steel fittings 50, 51 and52 extending through the top of the chamber, standard polyvinylchloridecouplings are provided. For clarity the couplings are not shown in FIGS.4 and 5.

The chamber is now prepared and ready for storage in a storage rackawaiting its next use. Where the apparatus is used by a single patientas in home dialysis, the patient may simply leave the chamber with thecoil in the dialysis machine for storage. Thus it will be ready forreuse without any movement of the chamber. Reuse of the Coil Chamber 41is placed in the dialysis machine and the arterial lines 34 connected tothe blood pump 32. The

bottom valve 53 is opened to discharge the contents of the chamber andthe dialysis machine is simultaneously placed, in the upper compartmentdrain mode. 500 ccs of sterile normal saline is then pumped through thecoil when the lid still sealed. The lid is then opened and the venousends of the coil removed and connected to a new venous line. Thepneumatic cuff is then inflated to the desired pressure shown on gage Gby bulb B and the lid semi-closed as described above at the start of thecycle. Another 500 ccs of saline is pumped through the coil whiledialyzing the coil against water in the upper compartment. The coileffluent is then tested to make certain that the sterilizing solutionhas been removed. Such tests are standard practice and form no part ofthe present invention. The apparatus is now ready for dialysis of thepatient.

The sterilizing solution employed should not have any deleteriouseflects on the membrane. Presently it is preferred to use a sterilizingsolution containing about 3.5 parts of formaldehyde by weight and waterto make parts total. This sterilizing solution and procedure has beenfound suitable for use, for example, with Travenol Dialyzers such as theUltraflow and Chronocoil 90 made by Travenol Laboratory, Morton Grove,Illinois.

The sterilizing solution employed has been found to increase the burststrength of the kidney coil membrane.

Thus there has been disclosed an improved method of hemodialysis, amethod of reusing an artificial kidney coil, a method of improving theburst strength of an artificial kidney membrane, and an apparatus whichis simple to use, avoids handling of the artificial kidney coil, andpermits sterilization of the artificial kidney coil.

The chamber may be made of glass, polymethylmethacrylate, polycarbonateor other plastics which can be sterilized and which will be resistant tothe fluids to which it would be exposed in use.

It will be appreciated that only one form of the device has beendisclosed and that other hardware such as other mechanical latches,valves, etc., may be employed without departing from the spirit of theinventron.

I claim:

1. An apparatus for use with a hemodialysis machine having an outletport for supplying a hemodialysis fluid,

a. Anl open chamber for receiving an artificial kidney cor b. conduitmeans extending from the bottom of said chamber adapted to mate with theoutlet port of the hemodialysis machine,

c. valve means for selectively closing said conduit means; and

d. cover means for sealing closed said open chamber.

2. The apparatus of claim 1 wherein said cover is hinged to saidchamber.

3. The apparatus of claim 2 having means for latching the cover in apartially open position.

4. The apparatus of claim 1 wherein said chamber is formed oftransparent material.

15. The apparatus of claim 4 wherein said material is g ass.

6. The apparatus of claim 4 wherein said material is a plasticsresistant to solutions employed in hemodialysis.

7. The apparatus of claim 1 including conduit means extending throughthe cover for receiving tubes connected to said artificial kidney coil.

1. An apparatus for use with a hemodialysis machine having an outlet port for supplying a hemodialysis fluid, a. An open chamber for receiving an artificial kidney coil, b. conduit means extending from the bottom of said chamber adapted to mate with the outlet port of the hemodialysis machine, c. valve means for selectively closing said conduit means; and d. cover means for sealing closed said open chamber.
 2. The apparatus of claim 1 wherein said cover is hinged to said chamber.
 3. The apparatus of claim 2 having means for latching the cover in a partially open position.
 4. The apparatus of claim 1 wherein said chamber is formed of transparent material.
 5. The apparatus of claim 4 wherein said material is glass.
 6. The apparatus of claim 4 wherein said material is a plastics resistant to solutions employed in hemodialysis.
 7. The apparatus of claim 1 including conduit means extending through the cover for receiving tubes connected to said artificial kidney coil. 